Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433459
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2007-02-08
Brief Title:
Combination Chemotherapy in Treating Young Patients With Hodgkins Lymphoma
Sponsor:
Christine Mauz-Körholz
Organization:
Martin-Luther-Universität Halle-Wittenberg
Study Overview
Official Title:
First International Inter-Group Study for Classical Hodgkins Lymphoma in Children and Adolescents
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more cancer cells It is not yet known which combination chemotherapy regimen is more effective in treating Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine whether the 5-year event-free survival EFS rate in pediatric patients with Hodgkins lymphoma with an adequate response after 2 courses of vincristine etoposide prednisone and doxorubicin hydrochloride OEPA without radiotherapy are consistent with an estimated target EFS rate of 90
Compare the EFS without a deterioration of patients treated with procarbazine hydrochloride vs dacarbazine treatment groups 2 and 3
Determine the treatment outcome of a standardized risk-adapted relapse strategy in these patients
Secondary
Determine whether the 5-year EFS rate in patients with Hodgkins lymphoma with an inadequate response after 2 OEPA courses and standard involved-field radiotherapy are consistent with an estimated target EFS rate of 90
Determine whether a positive positron emission tomography scan before planned high-dose chemotherapy with autologous stem cell transplantation has a negative prognostic significance
Compare the effect of dacarbazine vs procarbazine on the rate of infertility in males and premature menopause in females treatment groups 2 and 3
Tertiary
Determine the impact of real-time central staging and response assessment on treatment outcome in these patients
OUTLINE This is a randomized controlled parallel-group open-label multicenter study Patients are stratified according to staging and response assessment central vs local and disease stage IAB or IIA first-line treatment group 1 vs I_EAB II_EA IIB or IIIA first-line treatment group 2 vs II_EB III_E AB IIIB or IVAB first-line treatment group 3
First-line treatment group 1 Patients receive oral prednisone or prednisolone 3 times daily on days 1-15 vincristine IV on days 1 8 and 15 doxorubicin hydrochloride IV over 1-6 hours on days 1 and 15 and etoposide or etoposide phosphate IV over 1-2 hours on days 1-5 OEPA
Treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity Patients are assessed by fludeoxyglucose F 18 positron emission tomography 18FDG-PET scan Patients with inadequate response undergo radiotherapy within 35 days after completion of OEPA
First-line treatment group 2 Patients receive OEPA as in group 1 After completion of OEPA patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral prednisone or prednisolone 3 times daily and oral procarbazine hydrochloride 2-3 times a day on days 1-15 and vincristine IV and cyclophosphamide IV over 1 hour on days 1 and 8 COPP
Arm II Patients receive oral prednisone or prednisolone 3 times daily on days 1-15 dacarbazine IV over 15-30 minutes on days 1-3 and vincristine IV and cyclophosphamide IV over 1 hour on days 1 and 8 COPDAC
In both arms treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity Patients are assessed by 18FDG-PET scan Patients with an inadequate response undergo radiotherapy within 35 days after completion of COPP or COPDAC
First-line treatment group 3 Patients receive OEPA as in group 1 After completion of OEPA patients are randomized to 1 of 2 treatment arms
Arm I Patients receive COPP as in arm I of group 2
Arm II Patients receive COPDAC as in arm II of group 2 In both arms treatment repeats every 28 days for 4 courses in the absence of unacceptable toxicity Patients are assessed by 18FDG-PET scan Patients with an inadequate response undergo radiotherapy within 35 days after completion of COPP or COPDAC
Patients with biopsy-confirmed disease progression OR relapse after first-line treatment on this study or on protocols DAL-HD 90 GPOH-HD 95 GPOHHD 2002 Pilot or similar treatment proceed to second-line therapy Patients are stratified according to relapseprogression status late relapse from first-line treatment group 1 second-line treatment group 1 vs early relapse from first-line treatment groups 1 2 or 3 or late relapse from first-line treatment groups 2 or 3 second-line treatment group 2 vs disease progression second-line treatment group 3 Patients undergo a 18FDG-PET scan prior to beginning second-line therapy
Second-line treatment group 1 Patients receive ifosfamide IV over 22 hours and etoposide IV over 1-2 hours and oral prednisone three times daily on days 1-5 IEP Patients then receive doxorubicin hydrochloride IV over 1-6 hours bleomycin IV vinblastine IV and dacarbazine IV over 15-30 minutes on days 22 and 36 ABVD Treatment repeats every 50 days for 2 courses in the absence of disease progression or unacceptable toxicity
After chemotherapy treatment patients undergo radiotherapy
Second-line treatment group 2 Patients receive IEP and ABVD as in group 1 Autologous stem cells are collected after course 1 or 2 of IEPABVD
After chemotherapy patients with an adequate response undergo radiotherapy Patients with an inadequate response undergo high-dose chemotherapy comprising carmustine IV over 1-2 hours on day -7 etoposide IV and cytarabine IV over 30 minutes twice daily on days -6 to -3 and melphalan IV over 1½ hours on day -2 Patients then undergo autologous hematopoietic stem cell transplantation HSCT
Patients undergo a 18FDG-PET scan on day 50-54 Patients with 18FDG-PET scan positive disease undergo radiotherapy
Second-line treatment group 3 Patients receive IEP and ABVD as in group 1 All patients then undergo high-dose chemotherapy and HSCT as in group 2
Patients undergo a 18FDG-PET scan on day 50-54 Patients with 18FDG-PET scan positive disease undergo radiotherapy
After completion of study therapy patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 2150 patients will be accrued for this study
Primary
Determine whether the 5-year event-free survival EFS rate in pediatric patients with Hodgkins lymphoma with an adequate response after 2 courses of vincristine etoposide prednisone and doxorubicin hydrochloride OEPA without radiotherapy are consistent with an estimated target EFS rate of 90
Compare the EFS without a deterioration of patients treated with procarbazine hydrochloride vs dacarbazine treatment groups 2 and 3
Determine the treatment outcome of a standardized risk-adapted relapse strategy in these patients
Secondary
Determine whether the 5-year EFS rate in patients with Hodgkins lymphoma with an inadequate response after 2 OEPA courses and standard involved-field radiotherapy are consistent with an estimated target EFS rate of 90
Determine whether a positive positron emission tomography scan before planned high-dose chemotherapy with autologous stem cell transplantation has a negative prognostic significance
Compare the effect of dacarbazine vs procarbazine on the rate of infertility in males and premature menopause in females treatment groups 2 and 3
Tertiary
Determine the impact of real-time central staging and response assessment on treatment outcome in these patients
OUTLINE This is a randomized controlled parallel-group open-label multicenter study Patients are stratified according to staging and response assessment central vs local and disease stage IAB or IIA first-line treatment group 1 vs I_EAB II_EA IIB or IIIA first-line treatment group 2 vs II_EB III_E AB IIIB or IVAB first-line treatment group 3
First-line treatment group 1 Patients receive oral prednisone or prednisolone 3 times daily on days 1-15 vincristine IV on days 1 8 and 15 doxorubicin hydrochloride IV over 1-6 hours on days 1 and 15 and etoposide or etoposide phosphate IV over 1-2 hours on days 1-5 OEPA
Treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity Patients are assessed by fludeoxyglucose F 18 positron emission tomography 18FDG-PET scan Patients with inadequate response undergo radiotherapy within 35 days after completion of OEPA
First-line treatment group 2 Patients receive OEPA as in group 1 After completion of OEPA patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral prednisone or prednisolone 3 times daily and oral procarbazine hydrochloride 2-3 times a day on days 1-15 and vincristine IV and cyclophosphamide IV over 1 hour on days 1 and 8 COPP
Arm II Patients receive oral prednisone or prednisolone 3 times daily on days 1-15 dacarbazine IV over 15-30 minutes on days 1-3 and vincristine IV and cyclophosphamide IV over 1 hour on days 1 and 8 COPDAC
In both arms treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity Patients are assessed by 18FDG-PET scan Patients with an inadequate response undergo radiotherapy within 35 days after completion of COPP or COPDAC
First-line treatment group 3 Patients receive OEPA as in group 1 After completion of OEPA patients are randomized to 1 of 2 treatment arms
Arm I Patients receive COPP as in arm I of group 2
Arm II Patients receive COPDAC as in arm II of group 2 In both arms treatment repeats every 28 days for 4 courses in the absence of unacceptable toxicity Patients are assessed by 18FDG-PET scan Patients with an inadequate response undergo radiotherapy within 35 days after completion of COPP or COPDAC
Patients with biopsy-confirmed disease progression OR relapse after first-line treatment on this study or on protocols DAL-HD 90 GPOH-HD 95 GPOHHD 2002 Pilot or similar treatment proceed to second-line therapy Patients are stratified according to relapseprogression status late relapse from first-line treatment group 1 second-line treatment group 1 vs early relapse from first-line treatment groups 1 2 or 3 or late relapse from first-line treatment groups 2 or 3 second-line treatment group 2 vs disease progression second-line treatment group 3 Patients undergo a 18FDG-PET scan prior to beginning second-line therapy
Second-line treatment group 1 Patients receive ifosfamide IV over 22 hours and etoposide IV over 1-2 hours and oral prednisone three times daily on days 1-5 IEP Patients then receive doxorubicin hydrochloride IV over 1-6 hours bleomycin IV vinblastine IV and dacarbazine IV over 15-30 minutes on days 22 and 36 ABVD Treatment repeats every 50 days for 2 courses in the absence of disease progression or unacceptable toxicity
After chemotherapy treatment patients undergo radiotherapy
Second-line treatment group 2 Patients receive IEP and ABVD as in group 1 Autologous stem cells are collected after course 1 or 2 of IEPABVD
After chemotherapy patients with an adequate response undergo radiotherapy Patients with an inadequate response undergo high-dose chemotherapy comprising carmustine IV over 1-2 hours on day -7 etoposide IV and cytarabine IV over 30 minutes twice daily on days -6 to -3 and melphalan IV over 1½ hours on day -2 Patients then undergo autologous hematopoietic stem cell transplantation HSCT
Patients undergo a 18FDG-PET scan on day 50-54 Patients with 18FDG-PET scan positive disease undergo radiotherapy
Second-line treatment group 3 Patients receive IEP and ABVD as in group 1 All patients then undergo high-dose chemotherapy and HSCT as in group 2
Patients undergo a 18FDG-PET scan on day 50-54 Patients with 18FDG-PET scan positive disease undergo radiotherapy
After completion of study therapy patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 2150 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EURONET-PHL-C1 | None | None | None |
| EU-20703 | None | None | None |
| EUDRACT-2006-000995-33 | None | None | None |
| CCLG-HD-2007-10 | None | None | None |